Figure 1.

ASMS data flows. This figure shows a conceptual model for data flows for ancillary studies whose primary
focus is analysis of stored specimens. In this scenario, data flows into the ASMS
from the primary study’s CTMS (which contains information on participants, visits,
consent and other pre-existing data) and specimen repository LIMSs (Laboratory Information
Management Systems, which contain information on stored specimens available for further
investigation). Before an ancillary study is initiated, the ASMS is used for hypothesis
generation and feasibility investigations based on specimen availability. Once a particular
ancillary study has been identified, a container for its data is established within
the ASMS. After the ancillary study has been approved, any additional participant
consents required for the study are collected by clinical sites and noted in the ASMS.
Requests for needed specimens (including material transfer agreements) are sent to
the appropriate specimen repositories, which in turn send stored specimens to appropriate
labs. The labs perform assays on the specimens and import the results to the ancillary
study container in the ASMS. Once the ancillary study is complete, results may be
repatriated to the primary study. Results may also be shared in publications or other
venues.

This model presumes that all data for the ancillary study is managed within the ASMS,
not the CTMS or an external system. It also presumes that external investigators can
be given access to the study within the ASMS. Under different assumptions, usage patterns
and data flows would change, but an ASMS could still prove helpful.

For example, if gathering new clinical data from study participants is a significant
piece of an ancillary study, using an organization’s existing CTMS for collecting
and managing clinical data might make the most sense. An ASMS could still be desirable
for other aspects of the study. For our collaborators, CTMSs have not proven amenable
to the kinds of queries necessary for hypothesis generation and participant identification.
Also, they are not ordinarily well-integrated with relevant LIMSs, so they do not
facilitate identification of specimen availability. An ASMS could be used for these
steps and others that are not typically supported by CTMSs or LIMSs, such as specimen
requests and assay data management